Transitional Cell Carcinoma
Conditions
Keywords
Combination, Chemotherapy,transitional cell carcinoma
Brief summary
The purpose of this study is to evaluate the efficacy of Gemcitabine plus Ifosfamind as second line chemotherapy in advanced transitional cell carcinoma in terms of response rate and overall survival .
Detailed description
Cisplatin-based combination chemotherapy produces a response rate of 40-70% in TCC patients. However, only less than 10% of the patients can achieve long-term remission. Until now, there is no standard chemotherapy for cisplatin-failed TCC patients. Both gemcitabine and ifosfamide have been identified to have response rates of 20% or more in pretreated TCC patients. It is thus reasonable to combine these two active drugs as a second-line treatment for TCC. Patients enrolled must have a pathologically proven urothelial transitional cell carcinoma (TCC) and must have exposed to one cisplatin-based combination chemotherapy for the advanced disease. GI regimen will be continued until maximal response.
Interventions
DRUGGemcitabine, Ifosfamide
Sponsors
National Taiwan University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed transitional cell carcinoma * Advanced / metastatic disease failed to prior chemotherapy (diagnostically confirmed disease progression during the treatment of last chemotherapy or within 6 months after the end of last chemotherapy) * Presence of at least one measurable disease which is defined as lesion that can be measured in at least 1 dimension as ³ 20 mm with conventional technique or ³ 10 mm with spiral CT scan * Performance status of ECOG 0, 1, 2 * Age 20 years or older * Life expectancy more than 3 months * Adequate hematopoietic function as defined below: * WBC ³ 3,000/uL * Platelets ³ 75,000/Ul * Adequate organ function as defined below: * Total bilirubin £ 1.5 ´ ULN * ALT / AST£ 5 ´ ULN * Creatinine £ 1.5 mg/dL * Adequate serum electrolyte concentration: * 4 mmol/L\<\[K+\] \<5.3 mmol/L * 0.74 mmol/L\<\[Mg2+\] \<1.03 mmol/ * 2.02 mmol/L\<\[Ca2+\]\<2.60 mmol/L * Result of ECG assessment: QTC \< 460 msec * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Received chemotherapy, radiotherapy, surgery, or other investigational drug within 4weeks prior to entering the study * Receiving other concurrent palliative chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period * Presence of CNS metastasis * Previous or current malignancy with the exception of curatively treated non- melanoma skin cancer or cervical carcinoma in situ * Presence of serious concomitant illness which might be aggravated by study medication: 1. Uncontrolled infection (active serious infections that are not controlled by antibiotics) 2. Peripheral neuropathy grade 2 or higher (by NCI common toxicity criteria in sensory or motor neuropathy) 3. Clinically significant arrhythmia (electrocardiogram QTc greater than 500 msec) 4. Prior myocardial infarction or serious coronary arterial disease within the last 12 months * Mental status is not fit for clinical trial. * Women of child-bearing potential (pregnancy or breast feeding)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | 2000~2006 |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Safety | 2000~2006 |
Countries
Taiwan
Outcome results
None listed